25-09-2006: Jerini AG announced the results of its two pivotal Phase III trials (FAST-1 and FAST-2) for the subcutaneous treatment of hereditary angioedema (HAE). In the FAST-2 study, the primary endpoint was reached, showing a significant reduction in the time to onset of symptom relief. While FAST-1 results were clinically relevant, the primary endpoint was not reached. A supportive analysis combining both studies showed a significant reduction in the time to onset of symptom relief. Secondary endpoints, such as patient and physician reported time to first improvement of symptoms, and the time to almost complete relief of symptoms showed highly significant results in favor of Icatibant. Based on the clinically relevant and consistent results of the two trials, the company intends to apply as planned for expedited reviews by the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) starting submission at year-end 2006, with potential launch in 2007.
Icatibant, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide-hormone bradykinin. Bradykinin has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks. Icatibant has been granted orphan drug status for the treatment of angioedema by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), potentially securing, upon approval, market exclusivity for seven and ten years, respectively. In addition, the FDA has granted fast-track designation to Icatibant in the indication HAE.
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